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  • FDA Date: 06/27/2017

    Pomalyst (pomalidomide) Capsules REMS

    Goals of the Pomalyst (pomalidomide) Capsules REMS Program

    The goals of the POMALYST risk evaluation and mitigation strategy are as follows:

    1. To prevent the risk of embryo-fetal exposure to POMALYST.

    2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System